Abbildung 10: Studienendpunkte
The outcome measures for the non-comparative extension phase were changed since there is no validity to compare between original Avonex and Rebif groups due to different Rx regimens prior to T and the fact that dropout reasons are different between groups. Thus the valid comparisons are the within patient comparisons prior to and after conversion to Rebif for the Avonex group and for comparability, the Rebif group pre and post-T. Similarly the proportion relapse-free cannot readily be compared pre-T and post-T since the time intervals are different and the populations have changed since study start and even comparing the same set of patients is not really valid as patients have been treated for 12-24 months prior to T. The only measures to assess are relapse and MRI (T2).